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    Summary
    EudraCT Number:2016-005159-25
    Sponsor's Protocol Code Number:V260-024-01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-12-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2016-005159-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and
    Immunogenicity of V260 in Healthy Chinese Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
    A.4.1Sponsor's protocol code numberV260-024-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02062385
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.5.2Functional name of contact pointSusan Kaplan, MD
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station,
    B.5.3.3Post codeNJ 08889-0100,
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305 1633
    B.5.5Fax number+1267305 6505
    B.5.6E-mailsusan.kaplan@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rotateq®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC,
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRotavirus Vaccine, Live, Oral, Pentavalent
    D.3.2Product code ROTATEQ
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPentavalent (G1, G2, G3, G4, and P1) Human-Bovine Reassortant Rotavirus Vaccine
    D.3.9.3Other descriptive nameROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT
    D.3.9.4EV Substance CodeSUB25745
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000000 to 280000 to <116000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of rotavirus gastroenteritis
    E.1.1.1Medical condition in easily understood language
    To see if the study vaccine (V260) works to prevent disease (diarrhea and vomiting) caused by the rotavirus germ in infants
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of 3 doses of V260 against rotavirus gastroenteritis caused by naturally-occurring rotavirus (regardless of serotype or disease severity), occurring at least 14 days following the third dose.
    E.2.2Secondary objectives of the trial
    (1)To assess the safety of V260 with respect to all adverse experiences (AEs) within 30 days after each dose of V260/placebo.
    (2) Objective: To evaluate the efficacy of 3 doses of V260 against severe rotavirus
    gastroenteritis caused by naturally occurring rotavirus (regardless of serotype)
    occurring at least 14 days following the third dose.
    (3) Objective: To evaluate the efficacy of V260 against any rotavirus gastroenteritis that
    occurs at least 14 days after the first dose in all subjects receiving at least one dose of
    V260.
    (4) Objective: To evaluate the efficacy of 3 doses of V260 against i) severe and ii) anyseverity
    rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4, and
    G-serotypes that contain P1A[8] (e.g., G9) that occurs at least 14 days following the
    third dose.
    (5) Objective: To evaluate the impact of V260 on occurrence of any and severe all -
    cause gastroenteritis.
    (6) Objective: To characterize the antibody responses against OPV antigens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy infants at least 6 weeks (42 days) and up to 12 weeks (84 days) of age at time
    of administration of the first dose of V260/placebo (Date of Birth is age Day 1).

    2. Parent/legal guardian who agrees to participate by giving written informed consent
    and is willing and able to comply with study requirements.
    E.4Principal exclusion criteria
    1. History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery.
    2. History of intussusception.
    3. Known or suspected impairment of immunological function, including Severe Combined
    Immunodeficiency (SCID).
    4. Subject with acute diseases, severe chronic diseases, or chronic diseases during the acute
    period.
    5. Subject with uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological diseases (Contraindications for OPV and DTaP)
    6. Known hypersensitivity to any component of the rotavirus vaccine, OPV, and DTaP.
    7. Prior administration of any rotavirus vaccines.
    8. Fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of vaccination or
    within the last 24 hours. Note: Defer the study vaccination visit until complete resolution
    of febrile illness.
    9. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal
    reflux disease [GERD] may participate in the study as long as the GERD is well controlled with or without medication.
    10. Receipt of intramuscular, oral, or intravenous corticosteroid treatment since birth. Note:
    Use of topical, ophthalmic, and inhaled steroids are permitted.
    11. Subjects residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, organ or bone marrow transplantation, or with those receiving anti-cancer or immunosuppressive chemotherapy including long-term systemic corticosteroids.
    12. Prior receipt of a blood transfusion or blood products, including immunoglobulins.
    13. Participation in another interventional study within 14 days prior to the first study
    vaccination or expected anytime during the study.
    14. Receipt of investigational or non-registered product other than study vaccines within 30
    days prior to the first study vaccination or planned use during the study period.
    15. Additionally, for those participating in Cohort 2 Immunogenicity Subgroup A and
    Subgroup B:
    a. Inability to obtain blood specimen at randomization visit. NOTE: Re-schedule visit
    so that baseline specimen may be obtained prior to the first vaccination.
    b. History of polio, diphtheria, tetanus, or pertussis disease.
    c. Previous vaccination against diphtheria, tetanus, pertussis or poliomyelitis.
    16. Any condition, which, in the opinion of the investigator, ma y interfere with the
    evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy against any severity of rotavirus gastroenteritis
    E.5.1.1Timepoint(s) of evaluation of this end point
    ≥14 days Postdose 3
    E.5.2Secondary end point(s)
    Efficacy against severe rotavirus gastroenteritis RVGE ≥14 days Postdose 3
    E.5.2.1Timepoint(s) of evaluation of this end point
    ≥14 days Postdose 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    China
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4040
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 4040
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and toddlers (28 days-23 months
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 4040
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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